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. 2012 Dec 12;2012(12):CD004950. doi: 10.1002/14651858.CD004950.pub3

Gradin 2004.

Methods Randomised controlled trial 
 I. Masking of randomisation ‐ low risk 
 II. Masking of intervention ‐ low risk 
 III. Masking of outcome assessment ‐ low risk 
 IV. Completeness of follow‐up ‐ high risk
Participants 120 full‐term infants at 3 to 5 days of age undergoing venepuncture for metabolic screening 
 Exclusion criteria: feeding problems or suspicion of illness 
 Group 1: 27 neonates 
 Mean (range) GA ‐ 39.4 (37 to 42) weeks 
 Mean (range) BW ‐ 3638 (2325 to 4425) grams 
 Group 2: 29 neonates 
 Mean (range) GA ‐ 39.5 (37 to 42) weeks 
 Mean (range) BW ‐ 3637 (2700 to 4830) grams 
 Group 3: 26 neonates 
 Mean (range) GA ‐ 39.4 (37 to 42) weeks 
 Mean (range) BW ‐ 3442 (2185 to 4560) grams 
 Group 4: 29 neonates 
 Mean (range) GA ‐ 39.4 (37 to 42) weeks 
 Mean (range) BW ‐ 3660 (3025 to 4950) grams
Interventions Group 1: Breastfeeding and 1 ml sterile water 
 Group 2: Breastfeeding and 1 ml 30% glucose 
 Group 3: Fasting and 1 ml sterile water 
 Group 4: Fasting and 1 ml 30% glucose
For breastfed group, breastfeeding was allowed for as long as the infant wanted within 45 minutes prior to blood sampling 
 For the fasting group, blood sampling performed at least 2 hours after the last feed 
 Venepuncture was done 1 minute after giving 30% glucose or sterile water
Outcomes PIPP 
 Visual Analogue Scale 
 Median crying time
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Low risk Adequate
Blinding (performance bias and detection bias) 
 All outcomes Low risk Masking was done by blinding the observer as to the assignments to study groups
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Some infants had to be excluded from the analysis because of missing data (problems with video tapes)
Selective reporting (reporting bias) Low risk All patients were accounted for
Other bias Unclear risk Protocol not available to compare